Epitel Receives FDA 510(k) Clearance for Two New Technologies: REMI Remote EEG Monitoring System for Ambulatory Use and REMI Vigilenz AI For Event Detection
April 25, 2024
SALT LAKE CITY–(BUSINESS WIRE)–Epitel, a leader in AI technologies for patient-focused brain health solutions, announced today it received U.S. Food and Drug Administration (FDA) 510(k) clearances for two new innovative technologies: REMI™ Remote EEG Monitoring System for Ambulatory (at home) use and REMI Vigilenz™ AI For Event Detection. REMI for Ambulatory use allows EEG recording in outpatient and home environments for an extended duration, while REMI Vigilenz AI for Event Detection analyzes and marks REMI EEG records for potential electrographic seizures to assist with ease and accuracy of interpretation.
“We are excited about how these two advances will shift the paradigm of brain health monitoring.”
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“Existing EEG monitoring systems have been cumbersome and restrictive for patients, and technical requirements and limitations have impeded providers’ ability to administer, record, and interpret EEG. REMI Ambulatory and REMI Vigilenz AI For Event Detection will help patients and providers make better-informed treatment decisions,” said Mark Lehmkuhle, PhD, Chief Executive Officer and Co-Founder of Epitel. “We are excited about how these two advances will shift the paradigm of brain health monitoring.”
Current outpatient and ambulatory EEG monitoring is often uncomfortable and inconvenient. Patients are unable to go about their daily activities, including something as simple as moving about their own house, due to the burdens of a fully wired system, while some patients may experience infrequent seizures that standard 72-hour ambulatory EEG studies may miss or be unable to classify seizures adequately.1 REMI Ambulatory allows for an extended EEG in the comfort of one’s home while going about daily activities. REMI Ambulatory leverages the same REMI Sensors used in REMI for Healthcare Facility Use and adds a mobile computing platform that allows patients and caregivers to mark when they’ve experienced an event or suspected event.
“Patients with infrequent seizures may go on for years without definitive diagnosis and characterization of their seizure events, which may result in either inappropriate medications or use of medications when not necessary. Most significantly, some patients may not be started on medications because the events were not thought to be seizures,” said Jong Woo Lee, MD, PhD, associate professor of neurology at Harvard Medical School.
Extended-duration ambulatory EEGs can often amass weeks’ or months’ worth of the data needed to detect and assess seizures accurately. This aggregation of data can be time-consuming for epileptologists to interpret and may cause lengthy delays for patients and providers trying to make informed treatment decisions. REMI Vigilenz AI for Event Detection leverages state-of-the-art proprietary machine learning to identify and annotate potential seizure events in REMI EEG records. The platform categorizes seizure-like events with four levels of confidence, improving ease and speed of interpretation. The FDA also cleared REMI Vigilenz AI for Event Detection with a Predetermined Change Control Plan (PCCP), a new program to help AI/ML-enabled devices to manage change. Under this Authorized PCCP, Epitel expects to train REMI Vigilenz AI further over time to improve its performance at detecting potential seizures, aiding physicians in providing better clinical care.
REMI Ambulatory and REMI Vigilienz AI For Event Detection will be available through select practices later this year. Clinicians and practices interested in partnering with Epitel can request additional information via www.epitel.com. Epitel is venture-backed by Catalyst Health Ventures (CHV), Genoa Ventures, Dexcom, OSF Ventures, Wavemaker 360, MedMountain Ventures and Salt Lake City Angels.
REMI Remote EEG Monitoring Indications For Use
The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted. REMI uses single use, single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration up to 30 days.
The REMI System uses the REMI Mobile software application that runs on qualified commercial off-the-shelf mobile computing platforms. REMI Mobile displays user setup information to trained medical professionals and provides notifications to medical professionals and ambulatory users. REMI Mobile receives and transmits data from connected REMI Sensors to the secure REMI Cloud where it is stored and prepared for review on qualified EEG viewing software.
REMI does not make any diagnostic conclusion about the subject’s condition and is intended as a physiological signal monitor. The REMI System is indicated for use with adult and pediatric patients (6+ years).
REMI Vigilenz AI For Event Detection Indications For Use
REMI Vigilenz AI For Event Detection is indicated for the analysis of REMI Remote EEG Monitoring System electroencephalogram (EEG) recordings. REMI Vigilenz AI For Event Detection is intended to be used by physicians qualified to analyze and interpret EEG who will exercise professional judgment in using the information.
As an aide to the qualified physician’s REMI EEG review, REMI Vigilenz AI For Event Detection marks previously acquired sections of REMI EEG that may correspond to neurological events of interest indicative of potential electrographic seizures lasting at least 10 seconds in duration. REMI Vigilenz AI For Event Detection is indicated for use with adult and pediatric patients (6+ years).
REMI Vigilenz AI For Event Detection does not mark REMI EEG records in real time and does not provide any diagnostic conclusion about the patient’s condition to the user.
About Epitel, Inc.
Epitel™ is a digital health company modernizing brain health solutions to improve seizure monitoring and detection. By leveraging a proprietary cloud-based wearable sensor system and other innovative AI technologies, Epitel is empowering better treatment decisions by making EEG readily deployable and accessible. Visit www.epitel.com to learn more.
1https://www.medrxiv.org/content/10.1101/2023.04.12.23288496v1.full.pdf
Contacts
Maya Villanueva
Vuturo Group for Epitel
(415) 689-8414
maya@vuturo.com